FDA extends review of BioMarin's hemophilia A gene therapy

The US drug authority first asked for more data for hemophilia A treatment Roctavian, and now it wants more time to process it.
Photo: Manuel Balce Ceneta/AP/Ritzau Scanpix
Photo: Manuel Balce Ceneta/AP/Ritzau Scanpix
by albert rønning-andersson, translated by daniel pedersen

The US Food and Drug Administration (FDA) says it will extend its review of hemophilia A treatment Roctavian (valoctocogene roxaparvovec), reports the drug’s maker, BioMarin, in a press release.

Already a subscriber?Log in here

Read the whole article

Get access for 14 days for free. No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.

With your free trial you get:

  • Access all locked articles
  • Receive our daily newsletters
  • Access our app
!
!
Must contain at least 6 characters
!
Must contain at least 2 characters
!
Must contain at least 2 characters

Get full access for you and your coworkers

Start a free company trial today

Sign up for our newsletter

Stay ahead of development by receiving our newsletter on the latest sector knowledge.

!
Newsletter terms

Front page now

Further reading